Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Leaks
Haemonetics is recalling 1,340 units of Cell Saver 5/5+ Fastpacks because potential leaks in the inner core may cause fluid trapping and incomplete washing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to incomplete washing of blood products, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Haemonetics Corporation is recalling 1,340 units of CS5/5+ Fastpacks, 125 mL, 20° Res Autotransfusion Device. These products are intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recall covers products manufactured between October 2014 and October 2019 with catalog number 0265F-00.
The recall is being issued because the inner core of the bowl sets may develop leaks. This defect could result in fluid being trapped inside the bowl core, which may cause a long empty device error message and the possibility of incomplete washing. The source text notes that there are no specific lots identified with bowl cracks and that instructions to check for cracks are missing from the Instructions for Use (IFU).
The affected products were distributed worldwide, including nationwide in the United States and in various countries in Asia, Europe, and Oceania. Healthcare facilities and users should stop using the affected Fastpacks and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 1,340
Distribution
Part of a larger recall action
This product is one of 22 recalled by Haemonetics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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